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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
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07/09/2014 Sterility 14-437 ASTM ISO 52701 First edition 2013-11-15 Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
07/09/2014 Sterility 14-436 ASTM ISO 52628 First edition 2013-11-15 Practice for dosimetry in radiation processing
07/09/2014 Sterility 14-435 ASTM F2251-13 Standard Test Method for Thickness Measurement of Flexible Packaging Material
07/09/2014 Sterility 14-434 ASTM F2228-13 Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method
07/09/2014 Sterility 14-433 ASTM F2227-13 Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method
07/09/2014 Sterility 14-432 ANSI AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities
01/30/2014 Sterility 14-430 ASTM ISO 51607 Third edition 2013-06-01 Practice for use of an alanine-EPR dosimery system
01/30/2014 Sterility 14-429 ASTM ISO 51275 Third edition 2013-06-01 Practice for use of a radiochromic film dosimetry system
04/04/2016 Sterility 14-428 ANSI AAMI ISO 11137-1:2006/(R)2010 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]
ISO 11137-1 First edition 2006-04-15 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]
01/30/2014 Sterility 14-427 ANSI AAMI ISO 13408-1:2008 (R2011) Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
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